PPE washing and drying station Lassa ward Owo
Improving outcomes and clinical characterisation: a consultation to establish an appropriate Phase III clinical trial design for Lassa Fever
ISARIC and the Nigeria Centre for Disease Control have established a consultation group to develop the framework for a Phase III clinical trial design in preparation for future Lassa Fever clinical studies. This framework will be developed to ensure future studies can work within a standardised structure to facilitate the adoption of consistent trial methodologies and the generation of comparable results.
The consultation group is formed of approximately 30 researchers and clinicians who are leading experts in the field of Lassa Fever and who are involved in day-to-day patient management. The group has international representation with the majority of delegates residing in Lassa Fever-endemic countries.
An initial discussion about the requirement for randomised controlled trials for Lassa fever therapeutics was held in Irrua in 2019 between key stakeholders. This meeting identified a need for preparatory work to be undertaken ahead of Lassa fever clinical trials taking place.
Following this first meeting, a systematic review was conducted to describe the clinical characteristics of Lassa fever from presentation and throughout treatment and to identify patient outcomes and outcome measures that have historically been reported in publications of Lassa studies. These findings would form the basis of the consultation and serve as the first step in identifying key features of Lassa fever and Lassa fever clinical studies that will later contribute to the framework.
The framework is expected to be formed of four primary outputs:
- Core Eligibility Criteria (CEC) – the definition and characteristics of the study population
- Core Outcome Set (COS) – the what, how and when to measure in order to assess treatment efficacy
- Core Data Variables (CDV) – a list of recommended data variables for collection in all patients to standardise the characterisation of Lassa fever
- Standardised Lassa fever case definition (CD) – how to identify a patient with suspected Lassa fever
The consultation has been established with a quasi-Delphi methodology that will take place over the course of three rounds of review which are currently ongoing and expected to complete in December 2020.